EP0111796B1 - Spritzampulle - Google Patents

Spritzampulle Download PDF

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Publication number
EP0111796B1
EP0111796B1 EP83112127A EP83112127A EP0111796B1 EP 0111796 B1 EP0111796 B1 EP 0111796B1 EP 83112127 A EP83112127 A EP 83112127A EP 83112127 A EP83112127 A EP 83112127A EP 0111796 B1 EP0111796 B1 EP 0111796B1
Authority
EP
European Patent Office
Prior art keywords
ampoule
neck
stopper means
capsule
syringe according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
EP83112127A
Other languages
English (en)
French (fr)
Other versions
EP0111796A1 (de
Inventor
Gabriel Meyer
Ernst Howald
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medicorp Holding SA
Original Assignee
Meditec SA
Medicorp Holding SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Meditec SA, Medicorp Holding SA filed Critical Meditec SA
Priority to AT83112127T priority Critical patent/ATE19950T1/de
Publication of EP0111796A1 publication Critical patent/EP0111796A1/de
Application granted granted Critical
Publication of EP0111796B1 publication Critical patent/EP0111796B1/de
Expired legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2429Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/28Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/283Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/3129Syringe barrels
    • A61M2005/3132Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2459Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst

Definitions

  • the present invention relates to a syringe vial comprising a vial pre-injected with a liquid, in particular a drug to be injected, said vial being provided at its open end with a shutter and dispensing member movable axially relative to the bulb between a first so-called shutter position and a second so-called injection position, this member comprising at its external end a needle-holder tip and being traversed by a conduit connecting said tip to the interior of the bulb when said member is in its injection position, said conduit comprising an axial branch opening out on the outside of the needle holder end and a transverse branch communicating with said axial branch, the open end (s) of said transverse branch opening out inside the bulb.
  • Ampoule syringes of this type are already known, described in particular in French patent FR-A-714108. These devices consist of a bulb fitted with a sealing plug crimped at the open end of the bulb, and associated with a rotary or axial movement valve traversed by an axial duct, connected to a radial duct intended for lead into a cavity which is in communication with the interior of the bulb.
  • the opening and closing of the valve are obtained by rotation of the needle holder, in the example illustrated by FIG. 3 they are obtained by axial movement. opposite the bulb.
  • this construction comprises a closure plug in contact with the pharmaceutical product contained in the ampoule, a rotary valve or with axial movement housed in a central bore formed in the closure plug and also partially in contact with the product. to be injected, a special needle-holder cap adapted to the obturation cap and a spiral spring placed between the cap and the cap.
  • the manufacture of a special needle and needle holder tip is an expensive operation.
  • the fact that the needle is mounted on the needle holder tip when assembling the parts and especially when the bulb is pressurized, implies that the pressurized gas to be introduced into the bulb is injected through the syringe, which requires complicated equipment to avoid needle damage. Overpressure could also be obtained by filling in a pressurized enclosure, but the operation is complicated and its cost is high.
  • the pressurizing of the pharmaceutical liquid of the device can be carried out by injecting gas through the needle holder nozzle, previously put in place, followed by welding or bonding of the needle. Handling the needle is expensive because it requires special precautions. They must be done under sterile conditions and exclude any contamination, in particular by glue residue.
  • the drug is in contact with three elements made of different materials, the ampoule, the cap and the valve.
  • the seal between the plug and the valve is difficult to obtain unless the body of this valve is tightly tightened inside the plug, which implies a strong spring and counteracts the recoil of the bulb at the time of the injection.
  • the parts making up the bulb closure device are as follows: a plug, a valve housed in a cylindrical cavity of this plug, a crimping ring, a needle holder cap, a spring and a needle.
  • the manufacture of all these parts and their assembly are excessively expensive.
  • the preparation of the syringe for its use requires the following operations consisting of filling the ampoule with medicament, placing the stopper on this ampoule, fixing the stopper by means of a crimping ring, set up the valve in the central bore of the cap, set up the spring, inject a compressed gas into the bulb to put the liquid under pressure and fix the needle.
  • the needle whose shape is particular requires a relatively expensive special construction, the standard needles being unusable with this device. Finally, the piercing of an elastomer plug by the double needle can cause the migration of inert particles entrained by the medicated liquid in the patient's body and presents a real danger for the latter.
  • the present invention proposes to overcome the various drawbacks described above and to offer nursing staff a useful instrument, easy to handle, of economical construction and presenting for the patient all the guarantees of hygiene and cleanliness required.
  • the prefilled syringe ampoule according to the invention is characterized in that the ampoule has at its open end a neck of section narrowed relative to its body, in that the closure member is disposed at the inside of said neck in direct contact with its internal wall, this member having a substantially complementary shape and dimensions substantially equal to those of said neck and in that the transverse branch of said conduit is formed in the shutter member in position such that its end or ends opening into the interior of the bulb are closed by the internal wall of the neck of the bulb when the shutter member is in said closed position.
  • the pre-filled syringe ampoule according to Figures 1 and 2 comprises an ampoule 1 provided with a cylindrical neck 2, of section narrowed relative to its body and provided with an orifice.
  • This neck is provided with a peripheral bead 3 which cooperates with an annular bead 14 formed on the inner walls of a hollow capsule 4 adapted to the neck 2 of the bulb 1.
  • This capsule is integral with the closure member 5 engaged inside the neck 2 and fixed to the bottom 6 of the capsule so as to stand perpendicular to this bottom, in the cavity inside the capsule.
  • the obturation member 5 comprises an internal T-shaped duct 7, the central axial branch 8 of which opens into a needle-holder endpiece 9, and the transverse branch 10 of which opens against the interior walls of the neck 2.
  • the needle holder tip 9 is covered with a protective cap 15.
  • the junction between the body of the bulb 1 and its neck defines an annular shoulder 11 which corresponds to a shoulder 12 located between retaining fins 13 which equip the capsule 4 at its end opposite the bottom 6, and between the annular bead 14.
  • An elastic member, such as an O-ring 16 can be interposed between the shoulder 11 of the bulb and the 'shoulder 12 of the capsule to prevent the bulb accidentally passing from its storage position illustrated in FIG. 1 at its position of use shown in FIG. 2.
  • the O-ring has been removed through an appropriate opening made in the capsule or crushed under the effect of a pressure exerted on the bottom of the bulb 1.
  • the cap 15 was removed from the needle-holder tip and replaced by a needle 17.
  • the pressure exerted on the bottom 18 of the body of the bulb 1 has the effect of bringing the two shoulders 11 and 12 closer together and of clearing the lateral openings of the radial branch 10 of the inner conduit 7.
  • the liquid contained inside the ampoule and maintained under pressure can flow freely through this conduit and be injected by means of the needle 17 into the patient's body.
  • the presence of the elastic ring makes it possible to return the ampoule to its initial position and to stop the injection at any time.
  • the medicated liquid is in contact, during its storage, only with the material in which the closure member 5 is made, and with the walls of the body of the ampoule 1.
  • This material is an elastomer or any other suitable material having elastic characteristics.
  • the sealing of the bulb is ensured in a perfect manner between the rigid walls of the neck of the bulb and the flexible peripheral walls of the shutter member.
  • the shutter member includes a number of peripheral beads 19 which form as many tight seals between the two surfaces in contact.
  • Fig. 3 illustrates an alternative embodiment having the advantage of a particularly simple manufacturing.
  • the pre-filled syringe ampoule shown comprises, as previously, an ampoule 1 provided with a cylindrical neck 2.
  • This neck comprises at its end adjacent to its orifice a bead 23 constituting a rim, which cooperates with a bead 24 to ensure the retention of the capsule 25 on the bulb 1.
  • the bottom 26 of the capsule 25 carries a shutter member 27 provided with a T-shaped central duct 28.
  • the shutter member is attached and fixed at the bottom of the capsule by various means.
  • the capsule On the right part of the figure, the capsule carries on its inner wall a bead 29, preferably of annular shape which engages in an annular groove 30 of complementary shape to ensure the coupling of the closure member 27 and the capsule 25.
  • this coupling is done by folding down material by ultrasonic welding to form a bead 29.
  • This connection could also be made by a double thread 31 and 32 shown in broken lines.
  • the inner conduit 28 is composed of an axial branch of frustoconical shape 33 and of a transverse branch 34, the lateral openings of which open into a small recess 35 delimited by the wall of the neck of the bulb and by the walls of the obturator. surrounding these openings.
  • the axial branch 33 is extended by an axial conduit 36 passing through the bottom 26 of the capsule 25 and the needle-holder end piece 37.
  • a retaining bead 38 can equip the capsule 25 to block the needle in position on the door end piece - needle 37.
  • Fig. 4 illustrates another embodiment in which the shutter member 40 ′ has a frustoconical shape which corresponds to the frustoconical shape of the neck 41 of the bulb 1.
  • the shutter member comprises at its end inside the bulb 1 a retaining bead 42 whose diameter is greater than the minimum diameter of the body of the obturation member in the area where the transverse branch 43 of the inner duct opens 44.
  • the diameter of this retaining bead 42 is however less than inside diameter of the ampoule to allow a flow of the pharmaceutical liquid through the conduit 44 when the closure member is pushed towards the interior of this' capsule.
  • the bead 42 could have one or more axial notches 45 also allowing the flow of the liquid when the shutter member is in its injection position.
  • the taper of the closure member gives it the elasticity necessary to allow automatic recoil when the ampoule is filled and pressurized, and when the syringe ampoule is used to interrupt the 'injection.
  • Fig. 5 illustrates a variant in which the neck 50 of the bulb 1 is cylindrical and has an inner bead 51, preferably of annular shape, but which could also be replaced by discontinuous bosses.
  • the shutter member 52 has an annular groove 53 which cooperates with the bead 51 to ensure on the one hand the shutter member stops in the storage position and the elastic return of this member for filling and pressurizing the ampoule or to allow the injection to be interrupted.
  • the shutter member 52 has an inner duct 54 in the shape of a T and the neck 50 has an inner diameter smaller than that of the body of the bulb 51.
  • FIG. 6 differs from the embodiment of FIG. 5 in that the shutter member 60 has an enlarged zone 61 in the vicinity of its lower end. This area defines a bulge 62 elastic which is supported on a flange 63 surrounding the opening of the neck 64 of the bulb 1. This bulge constitutes a return member making it possible to return the shutter member 60 to its storage position at the end of filling of the container. ampoule or when the injection is stopped while using the syringe ampoule. Locking in the storage position is obtained by the cooperation of the rim 63 with an inner bead 65 fitted to the fins 66 of the capsule 67.
  • Fig. 7 shows a prefilled syringe ampoule comprising an ampoule 1 provided with a neck 71 of narrowed section whose edge is fitted with a bulge 72, a closure member 73 partially engaged inside this neck and a capsule 74 linked to the shutter member 73 and carrying at its lower end a needle holder tip 75 and at its upper end two lateral fins 76.
  • the capsule of this device has side walls provided with lateral openings 77 and 78 separated by an annular piece 79 or in the form of annular sectors intended to ensure the fixing of the shutter member in the central cavity of the capsule 74.
  • the insertion of the shutter member 73 in the capsule 74 is obtained thanks to the elasticity of the material.
  • the shutter member advantageously comprises an elastic peripheral bead 80 which collapses, as shown in FIG. 8 when the bulb 1 is pushed down in the direction of arrow A relative to the lateral fins 76 of the capsule 74.
  • This elastic bead also plays the role of a return spring which tends to bring the bulb back 1 in its initial position when the user releases the pressure he exerts on the bottom of this bulb. Under the effect of this pressure, the closure member 73 is crushed at its base against the bottom 81 of the capsule and increases the seal between these two components.
  • Each of the fins 76 has along its inner edge a protuberance 82 intended to cooperate with the bead 72 surrounding the end of the neck of the capsule 1 to ensure the retention of this capsule during storage of the pre-filled syringe ampoule.
  • the shutter member 73 has at its upper end 83 a bead 84 which is crushed under the effect of the pressure prevailing in the bulb and which ensures good sealing with the walls of the bulb 1.
  • the upper end of the shutter member relaxes and the liquid can flow through a peripheral notch 85 formed in the bead 84.
  • the syringe ampoule according to FIGS. 9 and 10 comprises a syringe body 100 whose bottom 101 is open to allow the introduction of a piston 102 intended to discharge a pharmaceutical liquid through the T-shaped inner conduit 90 of the closure member 91, associated with the capsule 92.
  • the closure device composed of the shutter member 91 and the capsule 92 has similarities with the shutter device composed of the shutter member 73 and the capsule 74 illustrated in FIGS. 7 and 8.
  • the capsule 92 comprises two annular elements 94 and 95 or in the form of annular sectors which constitute the first of the locking means of the shutter member 91 and the second a stop which cooperates with the rim 96 fitted to the neck 93 of the body 100 of the syringe.
  • the rim 96 is blocked by the retaining member 95 and the upper end of the closure member 91 closes the neck 93 of the syringe so that no liquid contained in the body of the latter can s 'flow through the central duct 90 in the form of a T which communicates with the axial duct 97 of the needle-holder endpiece 98.
  • the body of the syringe 100 has been pushed back so that the rim 96 abuts against the upper face of the annular retaining member 94 or in the form of annular sectors, which has the effect of clearing the lateral openings of the transverse branch of the central duct 90.
  • the piston 102 has been pushed down in the direction of the closure member 91 so as to push the medicament through the duct 90 in the direction of the duct 97 passing through the end-piece needle 98.
  • Fig. 11 shows a variant of the device illustrated in FIGS. 9 and 10. This embodiment differs from that of FIGS. 9 and 10 only in the shape and the arrangement of the lateral fins 110.
  • These fins 110 are preferably fixed to the upper end d 'A rod 111 directly linked to the upper edge of the capsule 112. They are advantageously two in number, which allows the operator to retain the body 100 of the syringe by means of the index and middle fingers and to press using the thumb on the rod 113 of the piston 114.
  • these two fins could be replaced by a cylindrical sleeve extending the capsule 102 over the entire length of the body of the syringe and having at its upper end a rim annular perpendicular to the axis of this sleeve.
  • the operator need only press on the bottom 101 of the body 100 of the syringe while holding the capsule by the fins 110 which are attached to it.
  • Figures 12 and 13 illustrate another embodiment of the syringe bulb described above comprising in this case a bulb 120 closed at one of its ends and closed at its neck 121 of section narrowed relative to the bulb 120 , by a shutter member 122 which also serves as piston.
  • This closure member comprises an interior cavity 123 in which is engaged the end 124 of a piston rod 125.
  • the central conduit for the flow of the pharmaceutical solution contained in the ampoule 120 in this case comprises a transverse branch 126 formed in the shutter member 122 and an axial branch 127 connected to the radial branch 126 and passing right through the piston rod 125.
  • the ampoule 120 contains a pharmaceutical solution which does not completely fill this ampoule in such a way that there remains an empty space 128.
  • the piston rod secured to the shutter member 122 is associated with two lateral arms 129, the upper ends of which are provided with fins 130 have notches 131 in which the edge 132 of the neck 121 of the can engage bulb 120.
  • a peripheral tongue 133 is formed all around the closure member 122 below the mouths of the transverse branch 126.
  • This tongue which is shown compressed between the body of the closure member and the inner walls of the neck of the bulb, is designed in such a way that it straightens when the shutter member enters the enlarged part of the bulb, and seals between the body of the shutter member and the interior walls of the bulb, in order to prevent the liquid to be injected from escaping between this shutter member and the walls of this bulb. Thanks to this tab which can be replaced by an elastic compressible bead, all of the medicated liquid necessarily flows through the radial channel of the obturation member.
  • the shutter member 122 can be coupled to the piston rod 125 by screwing as shown in the figures.
  • any other assembly method such as for example a hooking by means of spouts or a bead engaging in notches or a groove, could also be used for this purpose.
  • Fig. 14 shows a pre-filled syringe ampoule, the ampoule or cartridge 140 of which contains a medicated liquid 141 and a gas 142.
  • This gas is found at atmospheric pressure or at a slightly higher pressure obtained when the organ is put in place shutter 143 which has a cylindrical upper part 144 provided with a peripheral bead 145 provided with a notch 146 allowing the flow of the liquid 141 when the shutter member is in its position of use and a lower part 147.
  • This lower part is intended on the one hand to ensure the coupling of the shutter member with the piston rod 148 and on the other hand to ensure the seal between this shutter member and the walls of the bulb when pushed back inside this bulb.
  • the lower part 147 of the closure member comprises a narrowed region 154 provided with a groove 155 in which a protrusion 156 engages formed on the piston rod.
  • the latter comprises a bead 157, shown crushed because it is located in the neck of reduced diameter, and whose the, function is identical to that of the tongue 133 of the system of Figures 12 and 13.
  • the shutter member plays the role of a piston intended to push the liquid out of the cartridge.
  • the obturation member 143 comprises a central duct 149, the axial branch of which is connected to the duct 150 axially passing through the rod of the piston 148.
  • the capsule 151 is in this case composed of the piston rod 148 and a sleeve 152 integral with this piston rod.
  • the upper edge of this sleeve 152 comprises a crown 153 replacing the gripping fins of the embodiment according to FIGS. 12 and 13.
  • the example shown in fig. 15 constitutes a variant of that of the previous figure.
  • the shutter member 160 is made in one piece with the piston rod. With a view to coupling the shutter member 160 and the capsule 161, the latter comprises at its base, an annular groove 162 in which is engaged a bead or rim 163 formed in the vicinity of the base of the member shutter 160 below a retaining bead 164.
  • the other elements are substantially similar to those which make up the device shown in FIG. 14.
  • the sealing bead 157 of the closure member 143 is replaced by a sealing tongue 165 similar to that of the device in FIGS. 12 and 13.
  • Fig. 16 illustrates another variant according to which the shutter member 170 is independent of the piston rod 171 integral with the capsule 172.
  • a ring sealing 173 Between the upper end of the piston rod 171 and the shutter member is a ring sealing 173.
  • the transverse branch 174 of the inner duct 175 has only one branch and is formed between the ring 173 and the closure member 170.
  • the advantage of this device lies in the fact that the prefilled cartridge can be stored independently of the piston rod integral with the capsule. To bring the syringe bulb into the position of use, it suffices to push the closure member inside the bulb or cartridge 176 using the piston rod 171 by acting on the fins 177. and on the bottom 178 of the bulb.
  • Figures 17 and 18 illustrate a particularly advantageous variant in certain cases, and specifically reserved for low-volume subcutaneous injections such as insulin, morphine, heparin, etc.
  • the ampoule 180 has a relatively long neck 181 whose internal volume corresponds to the volume of drug 182 to be injected.
  • the obturator 183 closes the open end of the neck 181 and the medicament is surmounted by a relaxed gas 184 or at very slight overpressure.
  • Fig. 17 illustrates the relative position of the elements during storage, the piston rod 185 which may or may not be integral with the capsule 186 which may be in the form of a cylindrical sleeve or comprise two lateral arms provided with fins 187, which can be pre-assembled on the shutter member 183 or stored separately.
  • Fig. 17 illustrates the relative position of the elements during storage, the piston rod 185 which may or may not be integral with the capsule 186 which may be in the form of a cylindrical sleeve or comprise two lateral arms provided with fins 187
  • the syringe ampoule described can be used in a manner substantially equivalent to that of the pressurized gas ampoules described above.
  • the volume of the ampoule must be sufficient to contain the volume of liquid to be injected plus the compressed gas by the reduction in volume induced by the advance of the piston between its shutter and flow positions. It is possible to vary the volume of the bulb according to the maximum force that one wishes to apply to the piston. This force will depend on the reduction in volume that the gas must undergo.
  • a reduction of 50% requires a pressure of 1 bar.
  • a reduction of 50% makes it possible to expel the same quantity of liquid as the reduction in volume undergone by the gas. For example, if the liquid to be injected is 0.5 ml., The volume gained by the compression of the gas must be at least 0.5 ml., Which determines the length of the neck of the ampoule. .
  • the length of the neck is calculated precisely so that the reduction in volume occupied by the gas between the obturation position and the flow position, of the obturation member induces sufficient pressure so that the gas compressed by the reduction in volume , may expand by expelling the liquid.
  • a slight overpressure induced by the installation of the closure member should be sufficient to drive the liquid out of the conduit.
  • the space reserved for the compressed gas could in theory be reduced to the space that this gas could occupy at its incompressibility stage. In this case, significant force should be applied. It is more advantageous to reserve enough space for the gas after reduction in volume so that the force to be applied is relatively low. If it is desired to obtain a reduction in the volume of the gas greater than the volume of the liquid to be injected, it suffices to make the volume of the neck greater than the volume of liquid to be injected. It is thus possible to increase the speed of flow and more easily overcome the resistance of the penetration of liquid into the skin of the patient. But then we run the risk of injecting a little gas at the end of injection, which is in fact not dangerous in itself.
  • FIG. 19 and 20 illustrate another embodiment in which the shutter member 200 has at its base a cylindrical extension 201, fixed, for example by screwing in a base 202 integral with the capsule 203 having an outer sleeve 204 of which the upper edge carries the fins 205.
  • the central duct 206 of the shutter member is composed as before of an axial channel and a radial channel disposed at the upper end of the axial channel. Inside the latter, is housed a conduit 207 whose upper end is free and whose lower end is connected to the bottom of the interior cavity of the capsule. In the rest position illustrated in FIG. 19, the free end of the conduit 207 neutralizes the communication between the radial channel and the axial channel of the conduit 207.
  • the operator unscrews the base 202 from the cylindrical extension 201 by turning the capsule 203 relative to the pre-filled ampoule 208.
  • This has the effect of axially moving the conduit 207 downward, so that communication between the axial channel and the radial channel of the central conduit 206 is restored.
  • the orifices of the radial duct remain closed because they are directly in contact with the neck of the bulb, and due to the existence of the bead which covers the upper end of the organ of shutter 200.
  • the operator pushes on the bottom of the bulb by pulling on the fins 205 and thus brings the shutter member 200, acting as a piston in the body of the bulb whose diameter is greater than that of the neck.
  • the seal between the body of the bulb and the shutter member remains, in this position, provided by the bead 209 shown compressed in FIG. 19 and relaxed in FIG. 20.
  • This telescopic device is advantageous in that it allows storage in a relatively small footprint.
  • Figures 21, 22 and 23 illustrate a bulb- syringe with telescopic inner tube based on the same principles as those of the previous embodiment.
  • the channel 210 housed inside the axial branch of the T-shaped inner conduit 211 of the shutter member 212 is integral with a cylindrical piece 213 provided with two protrusions 214 in the form of sectors diametrically opposite angles (see in particular fig. 23) and which is housed inside a cylindrical cavity 215 formed at the base of the shutter member 212.
  • This bayonet system performs the same functions as the system screw coupling from the previous embodiment.
  • a quarter-turn rotation followed by an axial downward displacement of the capsule 216 relative to the ampoule 217 makes it possible to unclog the inner duct 211. Thereafter, the syringe ampoule is ready for use as described with reference to Figures 19 and 20.
  • Fig. 24 illustrates a method of mounting the piston rod 220, integral with the capsule 221 provided with fins 222, on the shutter member 223.
  • the shutter member 223 has a recess 224 in which engages a tip 225 which is used to couple said closure member with said piston rod.
  • the inner conduit 226 is off-center, so that, unlike the other embodiments, the capsule does not have axial symmetry and the needle-holder endpiece 227 is eccentric.
  • the transverse branch 228 communicates with the axial branch of the inner conduit 226.
  • Such an asymmetrical embodiment is particularly used when the volumes of drugs to be injected are large.
  • the tab 229 which is shown in this embodiment, could be replaced by a compressible bead.
  • Fig. 25 illustrates a particularly advantageous embodiment of an ampoule 230 comprising an annular constriction 231 which divides the interior of this ampoule into two chambers 232 and 233 respectively containing the medicinal liquid and the gas under pressure. Due to phenomena of surface tension of the particularly viscous medicinal liquid, the liquid remains constantly in the lower chamber 232 and cannot enter the upper chamber 233, whatever the position of this ampoule during its storage and / or transport. As a result, the liquid is always in contact with the closure member, which prevents direct contact of the pressurized gas with this member and guarantees that the liquid is kept under pressure, excluding any possibility of leakage of this gas.
  • the constriction 231 is located approximately at the upper 2/3 of the bulb, it can also be in any location, for example at the lower 1/3, as shown by broken lines at 231 '.
  • the lower chamber located between the constriction 231 ′ and the closure member (not shown) contains medicinal liquid which cannot escape towards the upper chamber. Therefore, the end of the shutter member inside the bulb is constantly bathed by the liquid and never comes into contact with the pressurized gas, regardless of the position of the bulb.
  • the upper chamber contains liquid and air whose relative position depends on the position of the bulb.
  • Throttling can be carried out directly by deformation of the walls of the bulb or be obtained by a ring attached to the inside of this bulb.
  • the parts lend themselves particularly well to a production of injected synthetic material and can then be assembled automatically. Filling can be carried out economically using conventional devices and under exceptional hygienic conditions.
  • the use does not offer any possibility of handling errors and the preparatory operations for the use do not generate any solid waste dangerous for the patient, such as broken glass due to the breakage of a bulb or particles of material synthetic material from the piercing of a obturator using a needle or other similar device.
  • the syringe bulb according to the invention meets both the economic requirements and the safety criteria sought by both manufacturers and users.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (24)

1. Ampullenspritze bestehend aus einer mit Flüssigkeit, insbesondere mit einem zu injizierenden Medikament, vorgefüllten Ampulle (1,100, 120, 140, 176, 180, 208, 217, 230), wobei besagte Ampulle an ihrem offenen Ende mit einem Organ (5, 27, 40, 52, 60, 73, 91, 115, 122, 143, 160, 170, 183, 200, 212, 223) zum Verschließen und zum Ausspritzen, welches bezüglich der Ampulle zwischen einer ersten Position, mit Verschlußposition bezeichnet, und einer zweiten Position, mit Injektionsposition bezeichnet, axial beweglich ist, wobei dieses Organ an seinem äußeren Ende einen Ansatz (9, 37, 75, 98, 134, 227) zum Aufnehmen einer Nadel aufweist und welches von einem Kanal (7, 28, 44, 54, 90, 149, 175, 206, 211, 226) durchbrochen ist, der besagten Ansatz mit dem Inneren der Ampulle verbindet, wenn sich besagtes Organ in der Injektionsposition befindet, wobei besagter Kanal ein Längsstück (10, 43, 34, 126, 174, 211) aufweist, weiches außen am Nadelträgeransatz mündet, und ein Querstück (10, 34, 43, 126, 174, 228), welches mit besagtem Längsstück in Verbindung steht, wobei das oder die offenen Enden des besagten Querstückes im Inneren der Ampulle münden, dadurch gekennzeichnet, daß besagte Ampulle an ihrem offenen Ende einen Hals (2, 41, 50, 64, 71, 93, 121, 181) mit einem Querschnitt aufweist, der bezüglich ihres Schaftes eingeschnürt ist, daß besagtes Verschlußorgan im Inneren des besagten Halses in direktem Kontakt mit seiner Innenwand angeordnet ist, wobei dieses Organ im wesentlichen gleichförmig und in den Dimensionen im wesentlichen gleich denen des besagten Halses ist, und daß das Querstück des besagten Kanales in dem Verschlußorgan derart angebracht ist, daß sein oder seine Enden, die im Inneren der Ampulle münden, durch die innere Wand des Ampullenhalses verschlossen sind, wenn sich das Verschlußorgan in besagter Verschlußposition befindet.
2. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß das Verschlußorgan an seinem Ende, in Kontakt mit dem Inneren der Ampulle, einen elastischen Umfangswulst (42, 84, 115) aufweist, dessen äußerer Durchmesser größer als der kleinste innere Durchmesser des Halses dieser Ampulle ist, und daß dieser Wulst mit mindestens einer Nut (45, 85, 146) am Umfang versehen ist, deren Tiefe etwa gleich der Dicke des besagten Wulstes ist.
3. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß das Verschlußorgan (40) eine kegelstumpfähnliche Form darstellt, die im wesentlichen die gleiche Form wie der kegelstumpfähnliche Hals (41) der Ampulle hat.
4. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß das Verschlußorgan mindestens eine Rille und mindestens einen Nebenwulst (19) aufweist, die auf der Außenseite dieses Organes unterhalb des Querstückes des besagten zentralen Kanales angebracht sind.
5. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß das Verschlußorgan (52) auf seiner Außenwand mindestens einen Umfangsbereich aufweist, um einen elastischen Anschlag für einen mit dem Hals der Ampulle (1) (Figur 5) fest verbundenen inneren Vorsprung (51) zu bilden.
6. Ampullenspritze nach Anspruch 5, dadurch gekennzeichnet, daß der Umfangsbereich durch einen Wulst gebildet ist, der am Umfang des Verschlußorganes (Figur 5) angebracht ist.
7. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß das Verschlußorgan einen ringförmigen Vorsprung (133, 157, 229) aufweist, der unterhalb der Mündung oder der Mündungen des besagten Kanalquerstückes (126, 228) liegt, wobei dieser Vorsprung so zusammendrückbar ist, daß er sich gegen die Wände des Ampullenhalses legt, wenn er sich im zusammengedrückten Zustand in der besagten Verschlußposition im Inneren des Halses befindet und daß er sich gegen die Wände des Ampullenschaftes legt, wenn er sich im entspannten Zustand in der besagten Injektionsposition im Inneren des Schaftes dieser Ampulle (Figur 12, 13, 14, 24) befindet.
8. Ampullenspritze nach Anspruch 7, dadurch gekennzeichnet, daß der Vorsprung als weiche Zunge ausgebildet ist.
9. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß der Ampullenhals einen durchlaufenden oder unterbrochenen Wulst (3, 23, 63, 72, 96) aufweist, der innen oder außen an dem besagten Ampullenhals angeordnet ist.
10. Ampullenspritze nach Anspruch 1. dadurch gekennzeichnet, daß das Verschlußorgan mit einer Kapsel (4, 25, 74, 92, 112, 151, 161, 172, 186. 209, 221) fest verbunden ist, die eine zentrale Aussparung aufweist, damit sie sich wenigstens teilweise um den Ampullenhais anpaßt, und daß das Verschlußorgan im Inneren dieser Kapsel koaxial zu dessen zentraler Aussparung befestigt ist.
11. Ampullenspritze nach Anspruch 10, dadurch gekennzeichnet, daß die Kapsel in der Nähe ihres Endes wo sich der Nadelträgeransatz befindet einen ausladenden Rand (13, 66, 76, 110, 130, 153, 177, 205, 222) aufweist.
12. Ampullenspritze nach den Ansprüchen 9 und 10, dadurch gekennzeichnet, daß die Kapsel mindestens einen Rückhaltewulst (14, 24. 65, 82) aufweist, der vorgesehen ist, um mit dem besagten durchlaufenden oder unterbrochenen Wulst der Ampulle zusammenzuwirken, um die Kapsel auf der Ampulle festzuhalten.
13. Ampullenspritze nach den Ansprüchen 9 und 10, dadurch gekennzeichnet, daß die Kapsel mindestens zwei seitliche mit Flügeln versehene Ansätze (13, 66, 76, 110, 130, 153, 177, 205, 222) aufweist und mit Rückhalteorganen versehen ist, weiche mit dem besagten durchlaufenden oder unterbrochenen Wulst der Ampulle zusammenwirken, um Anschläge zu bilden, welche die Verschlußposition des mit dieser Kapsel fest verbundenen Verschlußorganes definieren.
14. Ampullenspritze nach Anspruch 10, dadurch gekennzeichnet, daß das Verschlußorgan und die Kapsel Kupplungsmittel (29, 30 ; 79, 80 ; 91, 94; 155, 156 ; 163, 164 ; 201, 202 ; 213, 214) aufweist, die zum Fixieren des besagten Verschlußorganes im Inneren der besagten Kapsel dienen.
15. Ampullenspritze nach Anspruch 10, dadurch gekennzeichnet, daß das Verschlußorgan fest mit einer Kolbenstange (125, 148, 171, 185) verbunden ist, die ihrerseits mit der Kapsel fest verbunden ist (Fig. 12, 13, 14, 15, 16, 17, 18).
16. Ampullenspritze nach Anspruch 15, dadurch gekennzeichnet, daß die Kapsel zwei längliche Arme (129, 152) aufweist, die mit seitlichen Flügeln (130, 153) und mit Blockierungsorganen (131, 132) versehen sind, die mit dem Ampullenrand zusammenwirken, um das Verschlußorgan während der Lagerung in Verschlu- βstellung zu blockieren (Fig. 12, 13, 14, 15).
17. Ampullenspritze nach Anspruch 15, dadurch gekennzeichnet, daß die Kolbenstange und das Verschlußorgan aus einem Stück bestehen.
18. Ampullenspritze nach Anspruch 15, dadurch gekennzeichnet, daß die mit dem Verschlußorgan verbundene Kolbenstange eine nutzbare Länge aufweist, die mindestens gleich der inneren Länge der Ampulle ist.
19. Ampullenspritze nach Anspruch 10, dadurch gekennzeichnet, daß die Ampulle (180) einen Hals (181) hat, dessen Länge so gestaltet ist, daß die Verschiebung des Verschlußorganes im Inneren dieses Halses, um die besagte Injektionsposition zu erreichen, im Schaft der Ampulle einen Überdruck induziert, der zur vollständigen Entleerung der Flüssigkeit ausreicht (Figur 17, 18).
20. Ampullenspritze nach Anspruch 10, dadurch gekennzeichnet, daß die Kapsel ein rohrförmiges Teil aufweist, welches sich im Inneren des axialen Kanalstückes des Verschlußorganes verschieben kann, wobei dieses rohrförmige Teil dazu vorgesehen ist, das Querstück des besagten Kanales abzustellen, wenn sich das Verschlußorgan in der besagten Verschlußstellung befindet und um den Durchgang zwischen diesem Querstück und diesem axialen Stück freizugeben, wenn sich das Verschlußorgan in der besagten Injektionsposition befindet (Figur 19, 20, 21, 22).
21. Ampullenspritze nach Anspruch 20, dadurch gekennzeichnet, daß die kapsel und das Verschlußorgan Mittel (201, 202, 213, 215) aufweisen, die zusammenwirken, um eine relative Verschiebung zu gewährleisten, einerseits des Verschlußorganes und der Ampulle in ihre relativen Verschlußpositionen und andererseits der Kapsel, um letztere in die besagte Injektionsposition mitzunehmen (Figur 19, 20, 21, 22).
22. Ampullenspritze nach Anspruch 21, dadurch gekennzeichnet, daß die besagten Mittel (201, 202) einen mit Gewinde versehenen, mit der Kapsel fest verbundenen Sockel (202) und eine zulindrische, mit Gewinde versehene Verlängerung (201), die fest mit dem Verschlußorgan verbunden ist, aufweisen.
23. Ampullenspritze nach Anspruch 21, dadurch gekennzeichnet, daß die besagten Mittel (213, 215) ein zylindrisches Teil (213) aufweisen, das mit zwei fest mit der Kapsel verbundenen Vorsprüngen (214) in Form von Kreissegmenten versehen ist und eine im wesentlichen zylindrische Aussparung (215), die im Verschlußorgan angeordnet ist, wobei die zwei Elemente eine Bajonettkupplung darstellen.
24. Ampullenspritze nach Anspruch 1, dadurch gekennzeichnet, daß die Ampulle (230) eine ringförmige Einschnürung (231) aufweist, die vorgesehen ist, um den Innenraum dieser Ampulle in zwei Kammern (232, 233) aufzuteilen, wovon diejenige, die an einem Ende durch das Verschlußorgan begrenzt ist, nur Flüssigkeit enthalten kann, unabhängig von der Stellung der Ampulle.
EP83112127A 1982-12-20 1983-12-02 Spritzampulle Expired EP0111796B1 (de)

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AT83112127T ATE19950T1 (de) 1982-12-20 1983-12-02 Spritzampulle.

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WOPCT/CH82/00134 1982-12-20
CH8200134 1982-12-20

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EP0111796B1 true EP0111796B1 (de) 1986-05-28

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JP (1) JPS59120166A (de)
AT (1) ATE19950T1 (de)
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DE (1) DE3363818D1 (de)

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US9101725B2 (en) 2012-06-25 2015-08-11 Becton Dickinson France Prefillable drug delivery device

Also Published As

Publication number Publication date
JPS6136945B2 (de) 1986-08-21
EP0111796A1 (de) 1984-06-27
US4809711A (en) 1989-03-07
JPS59120166A (ja) 1984-07-11
CA1247962A (fr) 1989-01-03
DE3363818D1 (de) 1986-07-03
US4741737A (en) 1988-05-03
ATE19950T1 (de) 1986-06-15

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